Design Assurance Engineer
Reference Number: 050818BM MAIP
Location: MA
Position: Senior Design Assurance Engineer
Location: MA
Description:
Responsible for contributing to the design, development and management of projects for legacy products and support
of new products under development, with a focus on Design Quality and Compliance activities.
• Conduct product design control activities for new and sustaining product development efforts
• Support risk analysis activities, including design and process FMEA
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities
• Support Manufacturing Engineering in the creation of DMR, DHR, routers, bills of material, and specifications
for in- house / external manufacturing
• Conduct Internal Audits of the Quality System
• Interact with third-party test houses that conduct testing of company products
• Prepare for and participate in audits by external organizations, such as FDA, ISO etc.
• Perform all other essential duties as assigned
Requirements:
Experience Desired:
• Over 5 years of experience with Class II/III electro-mechanical medical device field
• In-depth knowledge of Design Controls, Risk Management practices, Corrective and Preventative Actions,
and regulatory requirements, such as FDA QSR's, ISO 13485, ISO 14971, I.S EN 62366, & ISO 11135, is essential
• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability,
tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools,
such as Minitab, is preferred
• Experience with supporting medical device compliance testing (e.g. EMC, EMI, IEC)
• Experience with lasers and optical technologies desired, but not necessary
Education Required:
• Bachelor's Degree in electrical engineering or similar engineering field
Brian Murray
bmurray@photonicsgrp.com
919-572-2292
The Photonics Group
